Cleared Traditional

K173583 - Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173583 · Exactech, Inc. · Orthopedic device
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Mar 2018
Decision
112d
Days
Class 2
Risk

K173583 is an FDA 510(k) clearance for the Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners. Classified as Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented (product code OQI), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 12, 2018 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Exactech, Inc. devices

Submission Details

510(k) Number K173583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2017
Decision Date March 12, 2018
Days to Decision 112 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OQI Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
Definition 1. Non-inflammatory Degenerative Joint Disease Including Osteoarthritis And Avascular Necrosis. 2. Rheumatoid Arthritis. 3. Correction Of Functional Deformity. 4. Treatment Of Non-union, Femoral Neck Fracture, And Trochanteric Fractures Of The Proximal Femur With Head Involvement, Unmanageable By Other Techniques. 5. Revision Procedures Where Other Treatment Or Devices Have Failed. Cemented And Uncemented Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.